132 Participants Needed

Escitalopram for Anxiety

(PrEcISE Trial)

AS
JB
ZN
HK
Overseen ByHeidi K Schroeder, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This double-blind, 12-week study will consist include132 anxious youth who are randomized (1:1) to standard or pharmacogenetically-guided escitalopram dosing. Block randomization (1:1) will be stratified by sex and metabolizer status.

Will I have to stop taking my current medications?

The trial requires that participants have not been treated with SSRIs (a type of antidepressant) within 12 weeks of starting the study and not be on any medication with psychiatric effects that need more than 5 half-lives to clear from the body. If you're on such medications, you may need to stop them before joining the trial.

What data supports the effectiveness of the drug escitalopram for anxiety?

Research shows that escitalopram is effective in treating various anxiety disorders, including generalized anxiety disorder, social anxiety disorder, and panic disorder. It is well-tolerated and often works faster than similar drugs like citalopram, making it a good option for managing anxiety.12345

Is escitalopram generally safe for humans?

Escitalopram is generally considered safe for humans, with a low rate of people stopping treatment due to side effects. Common side effects include nausea, insomnia, and dry mouth, but these are usually mild.12678

How does the drug escitalopram differ from other treatments for anxiety?

Escitalopram is unique because it is the most selective SSRI (selective serotonin reuptake inhibitor) available, which means it specifically targets serotonin levels in the brain to help reduce anxiety. It is effective for a broad range of anxiety disorders and is well-tolerated, offering advantages over other treatments like benzodiazepines, which can have more side effects.1491011

Research Team

JR

Jeffrey R Strawn, MD, FAACAP

Principal Investigator

University of Cincinnati

LB

Laura B Ramsey, PhD

Principal Investigator

Children's Mercy Kansas City

Eligibility Criteria

This trial is for youths aged 12-17 with generalized, social, or separation anxiety disorder. They must have a certain severity of anxiety, no recent psychotherapy initiation, and be English-speaking. Participants need normal physical exams and EKGs, not be pregnant or drug-positive, and use reliable contraception if sexually active.

Inclusion Criteria

I am between 12 and 17 years old.
Your overall level of symptoms is rated as moderate to severe by the doctor during two visits.
Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of the investigational product
See 15 more

Exclusion Criteria

You have a mood disorder like depression, eating disorder, bipolar disorder, or psychotic disorder, except for specific types of depression and anxiety disorders.
A positive urine drug screen
You have experienced allergies, intolerance, non-response, or extreme sensitivity to escitalopram.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard or pharmacogenetically-guided escitalopram dosing for 12 weeks

12 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Escitalopram
Trial OverviewThe study tests escitalopram dosing in anxious youth over 12 weeks. It's double-blind with participants randomly assigned to standard dosing or doses guided by their genetics. The randomization considers sex and how well their body processes drugs.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Standard dosingExperimental Treatment1 Intervention
Patients randomized to standard dosing (std) will initiate escitalopram at 5 mg daily and will then increase to 20 mg/day at week 4.
Group II: Pharmacogenetically-guided escitalopram dosingExperimental Treatment1 Intervention
Patients randomized to PGx-guided treatment, escitalopram titration will be based on CYP2C19 phenotype and predicted escitalopram exposure. In poor metabolizers (PM), escitalopram will be initiated at 5 mg daily and increased to 10 mg daily at week 4.

Escitalopram is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Lexapro for:
  • Major depressive disorder
  • Generalized anxiety disorder
🇪🇺
Approved in European Union as Cipralex for:
  • Major depressive episodes
  • Generalized anxiety disorder
  • Social anxiety disorder
  • Panic disorder with or without agoraphobia
  • Obsessive-compulsive disorder
🇨🇦
Approved in Canada as Cipralex for:
  • Major depressive disorder
  • Generalized anxiety disorder
  • Social anxiety disorder

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials
442
Recruited
639,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Findings from Research

In a study of 366 outpatients with panic disorder, escitalopram significantly reduced the frequency of panic attacks compared to placebo, demonstrating its efficacy in treating this condition.
Escitalopram was found to be safe and well tolerated, with a low rate of discontinuation due to adverse events, similar to that of the placebo group.
Escitalopram in the treatment of panic disorder: a randomized, double-blind, placebo-controlled trial.Stahl, SM., Gergel, I., Li, D.[2022]
Escitalopram, a more active isomer of citalopram, showed a faster onset of action and greater overall effectiveness in treating major depressive disorder compared to citalopram, with significant improvements in depression and anxiety symptoms observed as early as one week into treatment.
Both escitalopram and citalopram were effective in reducing symptoms of depression and anxiety compared to placebo, but escitalopram demonstrated statistically significant advantages over citalopram at multiple time points during the treatment period.
Efficacy comparison of escitalopram and citalopram in the treatment of major depressive disorder: pooled analysis of placebo-controlled trials.Gorman, JM., Korotzer, A., Su, G.[2019]
Escitalopram is an effective and well-tolerated treatment for various anxiety disorders and OCD, showing at least equal efficacy to paroxetine and a quicker response in panic disorder.
It has a favorable safety profile with fewer discontinuation symptoms compared to paroxetine, and its pharmacokinetics allow for convenient once-daily dosing.
Escitalopram: a review of its use in the management of anxiety disorders.Dhillon, S., Scott, LJ., Plosker, GL.[2019]

References

Escitalopram in the treatment of panic disorder: a randomized, double-blind, placebo-controlled trial. [2022]
Efficacy comparison of escitalopram and citalopram in the treatment of major depressive disorder: pooled analysis of placebo-controlled trials. [2019]
Escitalopram: a review of its use in the management of anxiety disorders. [2019]
Escitalopram in the treatment of generalized anxiety disorder. [2013]
Citalopram for social phobia: a clinical case series. [2019]
Safer citalopram use in primary care: Can staff education and prescribing prompts improve adherence to national guidance? A closed loop clinical audit, service evaluation and quality improvement study. [2023]
Escitalopram. [2022]
Escitalopram (Lexapro) for depression. [2022]
[Efficacy and tolerability of escitalopram in anxiety disorders: a review]. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Citalopram for social anxiety disorder: an open-label pilot study in refractory and nonrefractory patients. [2019]
[Effects of escitalopram on anxiety symptoms in depression]. [2022]